C.R. Bard Faces Lawsuits Over Meridian IVC Filter

Federal lawsuits alleging injuries from C.R. Bard’s Meridian inferior vena cava (IVC) filter are consolidated into a multidistrict litigation (MDL) in Arizona before U.S. District Judge David G. Campbell. According to court records, the MDL currently contains over 1,000 Meridian IVC filter claims. Plaintiffs in the litigation allege that the IVC filter, a blood clot-catching device, caused injuries when it broke within the blood vessel. Alleged injuries include blood vessel perforation, device migration, embolization and other complications. Plaintiffs allege Bard was aware of the risks but failed to warn patients or the medical community.

Parker Waichman LLP comments that IVC filter litigation has been mounting. The firm’s personal injury attorneys are offering free legal consultations to individuals with questions about filing an IVC filter lawsuit.
IVC filters are placed in the inferior vena cava, the major vein transporting blood from the lower body back to the heart, in order stop blood clots from getting lodged in the lungs. They are often used for patients who cannot oral anticoagulants. C.R. Bard is facing lawsuits alleging that the Meridian IVC filter was designed defectively and is prone to breaking or fracturing within the body, leading to potentially fatal complications.

One recent lawsuit was filed on Nov. 8 in the U.S. District Court for the District of Arizona. The plaintiff is a woman from Virginia who was implanted with the Meridian IVC filter in October 2012.

The U.S. Judicial Panel on Multidistrict Litigation (JPML) created an MDL for federal lawsuits involving the Bard Recovery, G2, G2X, G2 Express, Eclipse, Meridian and Denali IVC filters in August 2015. The goal of an MDL is to streamline the legal process and make complex litigation more efficient. The JPML does this by consolidating similar lawsuits to one court before one judge. Lawsuits filed into the Bard IVC filter MDL commonly allege that the devices caused injuries, that the filter was defectively designed and that Bard was aware of the risks but failed to warn patients or their doctors. Some lawsuits also allege that complications made retrieval difficult; certain IVC filters are designed to be removed once the risk of PE subsides.

Bard IVC Filter Background

Parker Waichman comments that IVC filter litigation has been on the rise. Additionally, Bard is not the only manufacturer facing personal injury lawsuits over the blood clot-catching devices. The firm notes that Cook Medical is also being sued over alleged IVC filter injuries, mostly from the Celect and Günther. Federal lawsuits have been consolidated into an MDL.

The U.S. Food and Drug Administration (FDA) has warned that IVC filter complications may be associated with how long the devices are left in the body. In a May 2014 safety communication, the agency noted that IVC filters were associated with reports of migration, filter fracture, embolization (where the entire filter or filter fragments move to the heart and lungs), perforation of the IVC and difficult retrieval. Considering these injury reports, the FDA advised physicians to remove IVC filters as soon as the risk of PE passes.

In September 2015, NBC released a two-part investigative report focusing on Bard IVC filter safety concerns. Specifically, NBC reported that the Recovery filter was associated with at least 27 deaths and 300 reports of non-fatal adverse events. The company did not recall the Recovery, NBC reports. The filter remained on the market until 2005. That year, the Recovery was replaced with the G2 filter series. Reportedly, the G2 series had the same issues and was also not recalled. There were also questions about how the filter was approved. Kay Fuller, a regulatory specialist who was recruited by Bard to help gain clearance for the Recovery IVC filter, says the company ignored her when she expressed safety concerns. She also notes that Bard submitted paperwork to regulators with her name on it, but tells NBC “That’s not my signature,”

In December 2015, NBC published another report on Bard IVC filters, this time focusing on why the company continued to sell the G2 filter series after receiving more adverse event reports. Reportedly, the model used to replace the Recovery also had issues; NBC reports the G2 was associated with at least a dozen deaths and hundreds of injury reports. Additionally, internal company documents suggest Bard was aware of the issue but never recalled the device.

In a confidential company memo, a Bard vice president cited “problems with…migration,” “tilting” and “perforation” with the G2. He noted that other Bard IVC filters were not associated with these issues, and asked “Why shouldn’t doctors be using that one rather than the G2?” Additionally, NBC reported on a confidential 2004 study showing that the Recovery was associated with higher rates of relative risk for death, filter fracture and movement compared to its competitors. An outside physician hired to conduct the study advised, “Further investigation…is urgently warranted.”

Dr. William Kuo, an interventional radiologist who runs Stanford Health Care’s IVC Filter Clinic and specializes in IVC filter removal, comments on the high rates of complications associated with Bard IVC filters. “All of the data that we’ve seen in our own studies, as well as other clinician researchers’, is that this device consistently fractures, consistently causes major complications,” said Dr. Kuo to NBC. “The number of complications, the frequency of severe failures makes it obvious that it was never safe to be implanted.”

Among other things, plaintiffs allege that Bard failed to conduct adequate testing for its devices. Lawsuits state that the Meridian was approved in 2011 through a 510(k) application, which means Bard did not have to conduct clinical trials to prove that the product is safe and effective. Devices approved through 510(k) only need to show that they are “substantially equivalent” to a previously approved device. The regulatory route is not intended for high-risk devices.

Filing an IVC Filter Lawsuit

If you or someone you know has questions about filing a Bard IVC filter lawsuit, contact the personal injury attorneys at Parker Waichman today. Our firm offers free, no-obligation case evaluations. For more information, fill out our online form or call 1-800-YOURLAWYER (1-800-968-7529).